To evaluate the long-term effects of GH-therapy on metabolic profile and risk factors for cardiovascular diseases in adults (aged 25-35 years) born SGA and compare this with non-treated adults born SGA and with adults born AGA.
ID
Source
Brief title
Condition
- Other condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Sexual function and fertility disorders
Synonym
Health condition
cardiovasculaire ziektes
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Insulin resistance
Secondary outcome
Blood pressure, body composition, lipid profile, endothelial function and
gonadal function.
Background summary
Epidemiological studies demonstrated an association between being born Small
for Gestational Age (SGA) and an increased risk of adult diseases such as
essential hypertension, non-insulin dependent diabetes mellitus and ischaemic
heart disease at a relatively young age. Subjects born SGA without spontaneous
catch-up growth, are nowadays treated with Growth Hormone (GH) to increase
adult height. GH has positive effects on the metabolic profile and
cardiovascular risk factors on the short-term, but long-term effects are less
known. Changes in the metabolic profile and development of cardiovascular
diseases develop over a long period of time. It is therefore important to
perform a long-term follow-up on previously GH-treated subjects born SGA, to
assess the long-term effects of GH treatment on metabolic profile and
cardiovascular risk factors, compared to non-GH-treated subjects born SGA and
compared to non-GH treated subjects born Appropriate for Gestational Age (AGA).
Study objective
To evaluate the long-term effects of GH-therapy on metabolic profile and risk
factors for cardiovascular diseases in adults (aged 25-35 years) born SGA and
compare this with non-treated adults born SGA and with adults born AGA.
Study design
Observational study comprising one day visit to the Erasmus MC Hospital,
Rotterdam.
Study burden and risks
During one day visit, various tests will be performed, including a general
physical examination, anthropometric measurements, a DEXA-scan, a Frequently
Sampled Intravenous Glucose Tolerance (FSIGT) test, blood pressure measurement,
an ultrasound of the carotid arteries and abdomen, an MRI cerebrum and abdomen
and a WAIS intelligence test. Prior to the visit, participants will be asked to
fill out questionnaires about quality of life and socio-economic status.
From our experience with follow-up studies with similar tests, participants do
not experience these tests as a burden. The only invasive test is the FSIGT
because it comprises the insertion of two intravenous lines, one for glucose
infusion and one for blood sampling. The DEXA-scan has a very low radiation
dose and takes only 10 minutes. The ultrasounds of the carotid arteries and
abdomen are non-invasive. In case of claustrophobia we will discuss with the
participant if the MRI can take place.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
Former participant of the IUGR-1, IUGR-2 or PROGRAM/PREMS study
Exclusion criteria
Duration of growth hormone treatment less than 4 years
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL50437.078.14 |